POS0126 CONTINUED TREATMENT WITH NINTEDANIB IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD): THREE-YEAR DATA FROM SENSCIS-ON
Authors: Y. Allanore, M. Vonk, O. Distler, A. Azuma, M. Mayes, A. James, V. Kohlbrenner, M. Alves, D. Khanna, K. Highland
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> In the randomised placebo-controlled SENSCIS trial in patients with SSc-ILD, nintedanib reduced the rate of decline in forced vital capacity (FVC) (mL/year) over 52 weeks by 44%, with adverse events that were manageable for most patients. SENSCIS-ON is an open-label extension study investigating adverse events and decline in FVC in patients with SSc-ILD treated with nintedanib over the longer term. <h3>Objectives</h3> To assess adverse events and decline in FVC in patients treated with open-label nintedanib over 148 weeks of SENSCIS-ON. <h3>Methods</h3> In the SENSCIS trial, patients received nintedanib or placebo until the last patient reached week 52 but for ≤100 weeks. Patients with SSc-ILD who completed SENSCIS or a drug–drug interaction (DDI) study of nintedanib and oral contraceptive in which female patients with SSc-ILD received nintedanib for ≥14 days to approximately 28 days were eligible to enter SENSCIS-ON. We analysed adverse events and changes from baseline in FVC (mL) over 148 weeks in patients who received nintedanib in SENSCIS and continued nintedanib in SENSCIS-ON ("continued nintedanib" group) and in patients who received placebo in SENSCIS or who received nintedanib for ≤28 days in the DDI study ("initiated nintedanib" group). Analyses were descriptive. Analyses of FVC were based on observed data available at the respective time-point. <h3>Results</h3> The continued nintedanib group comprised 197 patients and the initiated nintedanib group comprised 247 patients (231 from SENSCIS, 16 from the DDI study). In these groups, respectively, mean (SD) FVC at the start of SENSCIS-ON was 2379 (754) mL and 70.4 (18.1) % predicted and 2443 (814) mL and 70.8 (17.9) % predicted. In total, 126 (64.0%) and 125 (50.6%) patients in the continued nintedanib and initiated nintedanib groups, respectively, were still receiving nintedanib at week 148 of SENSCIS-ON. Diarrhoea was the most frequent adverse event (Table 1). Serious adverse events were reported in 76 (38.6%) patients in the continued nintedanib group and 95 (38.5%) patients in the initiated nintedanib group. Among patients who continued nintedanib and initiated nintedanib, respectively, 53 (26.9%) and 148 (59.9%) had ≥1 dose reduction and 72 (36.5%) and 131 (53.0%) had ≥1 treatment interruption. Adverse events led to discontinuation of nintedanib in 29 (14.7%) patients in the continued nintedanib group and 72 (29.1%) patients in the initiated nintedanib group. Mean (SE) changes in FVC from baseline to week 148 of SENSCIS-ON were −189.1 (29.5) mL in the continued nintedanib group and −126.4 (26.4) mL in the initiated nintedanib group (Figure 1). <h3>Conclusion</h3> The safety profile of nintedanib over 148 weeks of SENSCIS-ON was consistent with that reported in SENSCIS, characterized mainly by gastrointestinal events that were manageable for most patients. These results support the potential use of nintedanib in the long-term treatment of patients with SSc-ILD. <h3>Acknowledgements</h3> The SENSCIS and SENSCIS-ON trials were funded by Boehringer Ingelheim. Arata Azuma, Oliver Distler, Kristin B Highland and Maureen D Mayes were members of the SENSCIS Steering Committee. <h3>Disclosure of Interests</h3> Yannick Allanore Consultant of: AbbVie, AstraZeneca, Boehringer Ingelheim, Galderma, Janssen, Medsenic, Prometheus Biosciences, Grant/research support from: Alpine Immune Sciences, Corvus Pharmaceuticals, Medsenic, Madelon Vonk Speakers bureau: Boehringer Ingelheim, GlaxoSmithKline, Janssen, MSD, Novartis, Consultant of: Boehringer Ingelheim, Corbus Pharmaceuticals, Janssen, Grant/research support from: Boehringer Ingelheim, Ferrer, Galapagos, Janssen, Oliver Distler Speakers bureau: Bayer, Boehringer Ingelheim, Janssen, Medscape, Consultant of: 4P-Pharma, AbbVie, Acceleron Pharma, Alcimed, Altavant Siences, Amgen, AnaMar, Arxx, AstraZeneca, Beacon Pharmaceuticals, Blade Therapeutics, Bayer, Boehringer Ingelheim, Corbus Pharmaceuticals, CSL Behring, Galapagos, Glenmark Pharmaceuticals, Horizon Therapeutics, Inventiva, Kymera Therapeutics, Lupin, Miltenyi Biotec, Mitsubishi Tanabe, MSD, Novartis, Prometheus Biosciences, Rex Pharma Group, Roivant Sciences, Sanofi, Topadur Pharma, Grant/research support from: Boehringer Ingelheim, Kymera Therapeutics, Mitsubishi Tanabe, Arata Azuma Consultant of: Boehringer Ingelheim, Kyorin Pharmaceutical Co, Taiho Pharmaceutical Co., Toray, Grant/research support from: Boehringer Ingelheim, Taiho Pharmaceutical Co., Maureen Mayes Consultant of: Boehringer Ingelheim, Eicos, Galapagos, Mitsubishi Tanabe, Grant/research support from: Boehringer Ingelheim, Corbus Pharmaceuticals, Eicos, Galapagos, Horizon Therapeutics, Mitsubishi Tanabe, Prometheus Biosciences, Alexandra James Employee of: Employee of Elderbrook solutions GmbH, Bietigheim-Bissingen, Germany, which was contracted by Boehringer Ingelheim to assist with these analyses, Veronika Kohlbrenner Employee of: Boehringer Ingelheim, Margarida Alves Employee of: Boehringer Ingelheim, Dinesh Khanna Speakers bureau: Janssen, Consultant of: Actelion, Amgen, Boehringer Ingelheim, GlaxoSmithKline, Horizon Therapeutics, Janssen, Prometheus Biosciences, Talaris Therapeutics, Grant/research support from: Bristol Myers Squibb, Boehringer Ingelheim, Pfizer, Kristin Highland Speakers bureau: Bayer, Boehringer Ingelheim, Janssen, United Therapeutics, Paid instructor for: Bayer, Boehringer Ingelheim, Janssen, United Therapeutics, Consultant of: Boehringer Ingelheim, Janssen, MSD, United Therapeutics, Grant/research support from: Boehringer Ingelheim, Gossamer Bio, MSD, United Therapeutics.